rdf-syntax-grammar
mods:
  schema location: http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
  title info:
    title: Metabolite safety in drug development
  name:
    name part: Iverson, Suzanne L.
    name part: 1971-
    role:
      role term: editor.
  name:
    name part: Smith, Dennis A.
    role:
      role term: editor.
  type of resource: text
  genre: bibliography
  origin info:
    place:
      place term: nju
    date issued: 2016
    copyright date: 2016
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: remote
    extent: 1 online resource (xv, 331 pages : : illustrations.)
  abstract: "A reference on drug metabolism and metabolite safety in the development phase, this book reviews the analytical techniques and experimental designs critical for metabolite studies. It features case studies of lessons learned and real world examples, along with regulatory perspectives from the US FDA and EMA. & bull; Reviews the analytical techniques and experimental designs critical for metabolite studies & bull; Covers methods including chirality, species differences, mass spectrometry, radiolabels, and in vitro / in vivo correlation & bull; Discusses target pharmacology, in vitro systems aligned to toxicity tests, and drug-drug interactions & bull; Includes perspectives from authors with firsthand involvement in industry and the study of drug metabolites, including viewpoints that have influenced regulatory guidelines"--
  abstract: "This book focuses on the characterization of metabolites once a drug candidate is selected, featuring case studies to illustrate lessons learned and a perspective on future directions"--
  table of contents: Machine generated contents note: PREFACE LIST OF CONTRIBUTORS 1. Introduction: History of Metabolite Safety in Drug Development Dennis A. Smith and Suzanne L. Iverson 1.1. People, events and reaction 1.2. The rise of industrial drug metabolism 1.3. The appearance of MIST 1.4. The journey triggered by thalidomide- would present science have made a difference? 1.5. Key events from thalidomide to MIST 1.6. The purpose of this book 1.7. References 2. MIST and other metabolite guidelines in the context of industrial drug metabolism Gordon J. Dear and Angus N.R. Nedderman 2.1. A historical perspective 2.2. The emergence of the regulatory guidance documents 2.3. Impact of the guidelines 2.4. Future directions? 2.5. References 3. Metabolite technology -- qualitative and quantitative Gordon J. Dear and Andrew McEwen 3.1. Introduction 3.2. Clinical Samples 3.3. Pre-Clinical Samples 3.4. Radiolabelled test compounds 3.5. Mass Spectrometry 3.6. Nuclear magnetic resonance Spectroscopy 3.7. Accelerator mass spectrometry (AMS) 3.8. Further Reading 3.9. References 4. In Vitro methods for evaluation of drug metabolism: Identification of active and inactive metabolites and the enzymes that generate them R. Scott Obach, Amit S. Kalgutkar, and Deepak K. Dalvie 4.1. Introduction 4.2. The in vitro methods for metabolite profiling and identification 4.3. Application of in vitro methods for metabolite profiling in drug discovery and development 4.4. How well do in vitro metabolite profiles present in vivo metabolite profiles? 4.5 Pharmacologically active metabolites and their identification 4.6 Conclusion 5. Integrated reactive metabolite strategies J. Gerry Kenna and Richard A. Thompson 5.1 Introduction 5.2 Role of RMs in toxicity 5.3. Strategies for predicting, assessing and de-risking RM mediated toxicity 5.4. References 6. Understanding drug metabolism in humans -- in vivo Lars Weidolf and Ian D. Wilson 6.1. Abstract 6.2. Introduction 6.3. Preclinical Animal Studies 6.4. Early human in…
  note: eedited by Suzanne L. Iverson, Dennis A. Smith.
  note: Includes bibliographical references and index.
  subject:
    topic: Drugs
    topic: Metabolism
  subject:
    topic: Drugs
    topic: Safety measures
  subject:
    topic: Pharmacology
  subject:
    topic: Drugs
    topic: Side effects
  subject:
    topic: Pharmaceutical Preparations
    topic: metabolism
  subject:
    topic: Drug-Related Side Effects and Adverse Reactions
  subject:
    topic: Drug Evaluation, Preclinical
  subject:
    topic: Pharmacology
  classification: RM301.55 .M48 2016
  classification: 615.1
  classification: 2016 H-769
  classification: QV 38
  classification: SCI013010 MED071000
  related item:
    identifier: (DLC) 2016009167
  identifier: 9781118949689 (electronic bk.)
  identifier: 1118949684 (electronic bk.)
  identifier: 9781118949658
  identifier: 111894965X
  identifier: http://proxy.library.tamu.edu/login
  record info:
    record content source: NhCcYBP
    record creation date: 230502
    record change date: 20260214205402.0
    record identifier: in00004683026
    language of cataloging:
      language term: eng